The prevalence of valvular heart disease in the U.S. is tough to peg with any great precision, but an extrapolation of data from a new study would put the number at roughly 10.6 million people, a staggering number when the clinical and fiscal implications are considered.
Roche Holdings AG received CE mark approval for its Elecsys Dengue Ag test, a fully automated, high-throughput immunoassay to help diagnose acute dengue virus infections. With cases of dengue on the rise worldwide, the test, which delivers results in 18 minutes, offers high sensitivity and specificity across all four dengue virus serotypes, and will help clinicians confidently distinguish dengue from other illnesses causing acute fever.
Australian scientists have developed a simpler, less invasive way to detect Alzheimer’s disease that could make it easier for patients to access emerging disease-modifying therapies. Researchers from Australia’s Commonwealth Scientific and Industrial Research Organisation have identified blood-based biomarker tests capable of confirming amyloid plaque in the brain with accuracy comparable to the current gold standards using positron emission tomography scans and lumbar punctures.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anteris, Fastwave, Philips, Sweetch Health, Theranica Bio-Electronics.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bio-Techne, Clario Holdings, Conavi, Hyperion, Obviohealth, Otsuka, Recor, Tandem, Thermo Fisher, Vaxxas.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perimetrics, Roche, Strata Skin Sciences.
Stakeholders of all stripes have wondered whether transcatheter aortic valve replacement devices could match their surgically implanted cousins for device durability, but seven-year data from the Partner 3 trial seems to suggest that patients, physicians, payers and regulators need not fret as the topline numbers showed no statistically significant difference for outcomes such as mortality and morbidity.
Medtronic plc’s SPYRAL HTN-ON MED trial demonstrated significantly greater reduction in blood pressure with the Symplicity Spyral renal denervation procedure at three years than a sham procedure in a study presented as featured clinical research at the 2025 Transcatheter Cardiovascular Therapeutics conference in San Francisco.